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[S48] How Should We Set Up Our R&D Strategy and Target Product Profile? Key Learning from Real Cases
Session Chair(s)
Kotone Matsuyama, RPh
Professor, Department of Health Policy and Management
Nippon Medical School, Japan
How can we make the best choice when making decisions throughout different phases of clinical development? The Target Product Profile (TPP) is a strategic document to refine new market values for the pharmaceuticals development, and serves as a compass for developing development strategy. Based on the TPP to be developed, it is very important to maximize the value of the developmental target in the clinical practice and to carry out the earliest development by putting it into a viable clinical development plan. In this session, we would like to approach development strategy and its key points through the real cases of TPP and clinical development plans in companies and academia.
Speaker(s)
Significance of R&D Strategic Document through Regulatory Consultation and Review Process in PMDA
Tomoko Okudaira
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Deputy Review Director, Office of New Drug III
Significance and Examples of TPP and R&D Strategic Documents in Academia
Shinobu Shimizu, PhD
Nagoya Univeresity Hospital, Japan
Associate Professor, Department of Advanced Medicine
AMED R&D Management Based on Stage Gate and Drug Development Strategy
Yumiko Tomoyasu, DDS, PhD
Japan Agency for Medical Research and Development (AMED), Japan
Deputy Manager, Office of Promotion Coordination
Significance and Examples of TPP and R&D Strategic Documents in a Pharmaceutical Company
Michiyo Ohshima, MBA
Pfizer R&D GK, Japan
Senior Director, Head of Japan Portfolio and Project Management